NCT05068765

Brief Summary

This study aims to evaluate the effectiveness of a communication skills-focused psychoeducation program on the subjective well-being of primary caregivers of individuals with schizophrenia. Today, with the adoption of contemporary treatment models, the relatives of individuals with schizophrenia have become caregivers. Some caregivers who are not competent enough to communicate satisfactorily with a person diagnosed with schizophrenia may have problems in patient-patient-relative interaction. Problems that occur frequently in expressing oneself, giving appropriate reactions in interaction with the patient and creating a sense of trust are seen as a major source of concern by caregivers. In the solution of this problem, improving the communication skills of the caregiver and increasing the self-confidence and motivation to communicate with the individual diagnosed with schizophrenia is an area that should be addressed by mental health professionals. By using a communication skills focused psychoeducation program, it is aimed to increase the level of subjective well-being of caregivers of individuals with schizophrenia by establishing healthy and positive relationships, coping with the negative emotions and difficulties they face, realizing their strengths, and leading a happy and meaningful life. Within the scope of this aim, it was aimed to evaluate the effect of a communication skills focused psychoeducation program on the subjective well-being of caregivers of individuals with schizophrenia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

August 2, 2021

Last Update Submit

September 24, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • The change of the "subjective well-being scale" score averages of the participants in the communication skills psychoeducation group before and after the training

    After the 8-week training program was applied to the communication skills psychoeducation group, it is expected that the subjective well-being scale scores of the participants will increase. Subjective well-being scale data will be collected before and after the training. The scale will be repeated one month and three months after training. Subjective well-being scale consists of personal judgments and positive and negative emotional expressions about living spaces. The lowest score that can be obtained from the scale is 46, and the highest score is 230. A high score indicates a high level of subjective well-being. Quantitative data will be used to measure the change in participants' views and feelings before and after the training. The data will be analyzed using the Statistical Package for Social Sciences package program.

    12 months

  • The change of the "subjective well-being scale" mean scores of the participants in the communication skills psychoeducation group after the training compared to the mean scores of the control group participants

    After the training, the difference in the "subjective well-being scale" score averages of the communication skills psychoeducation and control group participants will be examined.After the 8-week training program was applied to the communication skills psychoeducation group, it is expected that the subjective well-being scale mean scores of the participants will increase compared to the control group.Control group participants will not receive any intervention. Subjective well-being scale data will be collected before and after the training. The scale will be repeated one month and three months after the training. Subjective well-being scale consists of personal judgments and positive and negative emotional expressions about living spaces. The lowest score that can be obtained from the scale is 46, and the highest score is 230. A high score indicates a high level of subjective well-being.

    12 months

  • The change of the "subjective well-being scale" score averages of the communication skills focused psychoeducation group participants after the training compared to the general psychoeducation group participants' mean scores

    After the training, the difference between the subjective well-being scale scores of the participants in the communication skills psychoeducation group and the scores of the participants in the general psychoeducation group will be examined. It is expected that the mean scores of the communication skills psychoeducation group will be higher than the general psychoeducation group. An 8-week training program will be applied to the communication skills focused psychoeducation group, and a general psychoeducation program will be applied to the general psychoeducation group. Subjective well-being scale data will be collected before and after the training. The scale will be repeated one month and three months after the training. The lowest score that can be obtained from the scale is 46, and the highest score is 230.A high score indicates a high level of subjective well-being.

    12 months

Study Arms (3)

control group

NO INTERVENTION

Once enrolled and consent is documented, eligible subject's will participate in the study for approximately six months.

communication skills psychoeducation

EXPERIMENTAL

Communication skills focused psychoeducation group will be given a communication skills-focused psychoeducation program for eight weeks, one session per week, for a total of eight sessions. The number of sessions was planned with reference to the study in which the effect of the psychoeducation program on general health and communication skills in caregivers of individuals with schizophrenia was investigated.Session groups will be formed from a single session of 60-90 minutes for each topic.

Other: Communication skills psychoeducation

general psychoeducation

EXPERIMENTAL

General psychoeducation group will be given a general psychoeducation program for four weeks, one session per week, in total. Session groups will be formed from a single session of 60-90 minutes for each topic.

Other: General psychoeducation

Interventions

Intervention explanations are explained in the groups section.

communication skills psychoeducation

İntervention descriptions are explained in the intervention groups section.

general psychoeducation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient receiving care has a diagnosis of schizophrenia,
  • Living with the patient receiving care for 6 months,
  • Being directly (full) responsible for the care of the patient being cared for,
  • Be over 18 years old,
  • Living in the city center of Zonguldak,
  • To be at least primary school graduate,
  • Having no hearing and comprehension problems,

You may not qualify if:

  • Having a history of substance abuse (excluding nicotine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bulent Ecevit University Health Practice and Research Hospital

Zonguldak, Turkey (Türkiye)

Location

Related Publications (1)

  • Gharavi Y, Stringer B, Hoogendoorn A, Boogaarts J, Van Raaij B, Van Meijel B. Evaluation of an interaction-skills training for reducing the burden of family caregivers of patients with severe mental illness: a pre-posttest design. BMC Psychiatry. 2018 Mar 27;18(1):84. doi: 10.1186/s12888-018-1669-z.

    PMID: 29587690BACKGROUND

Related Links

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Hülya Bilgin, Prof.

    Istanbul University-Cerrahpasa Florence Nightingale Nursing Faculty Mental Health and Psychiatric Nursing Department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 2, 2021

First Posted

October 6, 2021

Study Start

October 1, 2021

Primary Completion

October 30, 2022

Study Completion

December 30, 2022

Last Updated

October 6, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

All collected IPD.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
12 months

Locations